The Central Protocol and Data Monitoring Office (CPDMO) is a Shared Resource that provides a number of centralized clinical research protocol-related services. The primary objectives of the CPDMO Shared Resource are to support Cancer Center clinical investigators by providing assistance in developing high quality clinical protocols, ensuring that all appropriate institutional and Federal reviews have been accomplished prior to accruing participants, providing standard order sets for therapeutic protocols, ensuring appropriate research participant enrollment via a centralized clinical trial registration system, coordinating efforts to design and develop case report forms, ensuring appropriate scientific review, and monitoring of clinical research studies. The CPDMO is a key component of the Clinical Trials Infrastructure. It was proposed by the Clinical Academic Council and approved by the Director in 1995, replacing the Protocol Office which previously managed clinical research protocols. The CPDMO has grown from 5.5 FTEs to 26 FTEs (including the Investigational Studies Pharmacists) to meet the demands of an every-changing regulatory environment and to meet the institutional commitment to human subjects' protection and data integrity. A centralized research participant enrollment system was fully implemented in 1998, along with monitoring of protocol eligibility for 100% of participants who are enrolled on St. Jude protocols. In 1999, an automated clinical trials database application was installed. A program to monitor our institutional trials for protocol compliance, regulatory compliance and data quality was established in the fall of 2000. Therapeutic and non-therapeutic studies are monitored in accordance with the current Data and Safety Monitoring Plan (dated 2001). The office is heavily involved with the assurance of appropriate institutional, legal, scientific, and regulatory review of all clinical research protocols conducted at St. Jude. A recent review of processes showed that St. Jude's clinical research infrastructure is superior to that of benchmarked institutions, and provides researchers with unique opportunities that are unavailable elsewhere. The effort placed in monitoring and organization has had significant positive impact on the quality of research conducted at St. Jude. As the number of clinical trials with external collaborating sites increases, resources to support those sites have also been added, including monitors/auditors who review study information on site. Upgrades to the clinical trials database and enrollment system are ongoing to meet current and future needs. To meet the future needs of clinical research, the institutional clinical trials infrastructure will continue to evolve. The Institutional Data and Safety Monitoring Plan is being revised to incorporate a more risk-based approach to monitoring and auditing. The monitoring program will be moved into Cancer Center Operations in order to allow for real time monitoring of key aspects of the research. A separate institutional auditing function will review clinical research studies at regular intervals. Restructuring of CPDMO functions in the context of the Cancer Center and Institution will allow us to capitalize on strengths and to be good stewards of institutional resources.